TRAY FOR HOLDING STERILIZATION TARGETS
Disclosed embodiments include a tray configured for holding various sterilization targets. The tray may include a perforated floor member connected to a plurality of vertically oriented walls, which may also be perforated. Together, the floor member and walls define an internal cavity that includes at least one wire support for removably holding at least one sterilization target, such as a medical instrument and/or implant or components thereof, within the internal cavity. Each wire support may include two end inserts and a middle portion, the two inserts secured via connection means to one or more walls of the tray. The connection means may comprise mounting fixtures that further include a plurality of receiving slots or holes each configured to receive an insert. The wire supports may increase sterilant flow and circulation, thereby improving sterilization of instruments and/or implants held within the tray disclosed herein.
The present application relates to trays for holding various sterilization targets. More particularly, the present application provides perforated trays with at least one wire support for removably holding at least one medical instrument and/or implant and/or other sterilizable component during sterilization and methods for making the wire supports. The trays include connection means for securing the wire supports to the tray.
BACKGROUNDMedical instruments and/or implants often come in a wide range of diverse shapes and sizes, each being customized to perform highly specialized tasks with high precision. For ease of use and organization, assorted instruments are often packaged together in procedure-specific collections or kits, which are housed in various containers. Constructing these containers with the durability necessary to protect expensive medical instrumentation from damage is imperative, and the variety of stresses applied to such containers makes this a challenging task. For example, containers used to provide instruments for use on patients must be able to withstand the high heat and pressure typically associated with autoclave sterilization. The same containers may also be relied upon to house the instruments during shipping and storage. Throughout each of these processes, the instruments must be further shielded from the damage caused by instrument-to-instrument contact without diminishing the total holding capacity of each container.
In addition to protecting the instruments from damage, the containers must organize the instruments in a way that ensures their thorough sterilization. Specifically, the containers must arrange the instruments in a manner that maximizes their exposure to the steam and/or chemicals employed for sterilization. Internal structures for holding or propping variously-shaped instruments may be included for this purpose.
Current containers fail to successfully perform the aforementioned functions, especially with respect to instrument sterilization, and/or are expensive to manufacture. In particular, preexisting containers may comprise sterilization trays with brackets, posts, cut-out blocks, or fixtures to organize various instruments, but the materials and design of these internal features typically reduce or limit sterilant exposure to the instruments and disrupt overall sterilant flow and circulation. Some container designs are susceptible to breaking or cracking during transit or sterilization. Thus, improved trays for medical instruments and/or implants are needed to avoid the harmful consequences of incomplete sterilization and ensure safe storage and transport of expensive medical equipment.
SUMMARYA tray for holding sterilization targets is described that comprises: a perforated floor member; a plurality of vertically oriented walls connected to the floor member around a perimeter of the floor member such as to define an internal cavity, wherein one or more of the walls may be perforated; at least one wire support for removably holding and supporting against lateral or longitudinal movement at least one sterilization target within the internal cavity, wherein each wire support comprises two ends and a middle portion, the middle portion comprising at least two bends in a wire from which the support is made; and connection means associated with at least one of the plurality of vertically oriented walls for securing each end of the at least one wire support to the tray.
A method of forming a wire support for use in a tray for holding sterilization targets comprising: (i) a perforated floor member; and (ii) a plurality of vertically oriented walls connected to the floor member around a perimeter of the floor member, wherein one or more of the walls may be perforated and the floor member and walls together define a sterilization space enclosed by the tray is also described. The method comprising: using a computer aided design tool programmed with a dimensioned design description for the tray for holding sterilization targets, including the sterilization space, defining a location in the sterilization space for at least one sterilization target; using a computer aided design tool programmed with a dimensioned design description for the at least one sterilization target, identifying at least one contact point on the sterilization target, for supporting or positioning the sterilization target at its location in the sterilization space; using a computer aided design tool programmed with the bending capabilities of a wire bending machine and a wire specification, defining a wire path between two connection means associated with at least one of the plurality of vertically oriented walls for securing each end of the at least one wire support to the tray, said wire path defining a wire configuration extending between two end points of at least one wire support segment and passing through the at least one contact point and at least one wire connection segment at each end of the wire support segment defined by a connecting bend in the wire path; storing in a storage medium a wire path design file including the location of a plurality of end points of the support segments and connection segments and a radius or other specification of the connecting bends, said wire path forming a continuous path between the two connection means; transmitting to the control unit of the wire bending machine the wire path design file; and causing the wire bending machine to perform bending of a wire supplied to the bending machine as defined by the wire path design file, including forming an insert for each of the connection means by bending and cutting wire at each end of the wire path.
In the drawings:
Provided herein are improved trays for sterilizing, shipping, and storing various sterilization targets. For instance, the trays disclosed herein comprise one or more wire supports customized to removably hold specific medical instruments and/or implants or components thereof during sterilization processes, when they become sterilization targets. The wire supports are configured to increase sterilant flow, sterilant exposure, and the instrument-holding capacity of the trays while enhancing overall durability. The trays may also comprise perforated walls to further enhance the flow of sterilants, and connection means for securing variously-configured wire supports within each tray.
Referring to the drawings,
In the particular configuration shown in
As shown in
As further shown in
Perforations 27 may enhance the circulation and flow of various sterilants, allowing the sterilants to cover all surfaces of the sterilization targets, such as medical instruments and/or implants or components thereof, held within tray 1. Perforations 27 may be organized in various arrangements to direct the flow of sterilants in particular directions during a given sterilization process. For example, perforations 27 may be limited to opposing surfaces, e.g., side walls 11 and 13, to direct sterilant flow in one direction through tray 1. Perforations 27 may also be positioned to better accommodate different arrangements of multiple trays, e.g., vertical stacking, within a given sterilization chamber. For instance, perforations 27 may be positioned exclusively on cover 3 and floor member 5 to direct sterilant flow vertically through the top and bottom of each tray 1 stacked in an upright column. Such arrangements may also improve sterilant drainage at the conclusion of a sterilization process. Alternatively, perforations 27 may be included on each surface of tray 1 and cover 3 to maximize sterilant access to cavity 29. In addition to improving sterilant circulation and flow, perforations 27 may expedite cooling after sterilization by aerating tray 1. Furthermore, an increased number of perforations 27 may decrease the total weight of tray 1, making the tray easier to lift and handle.
The shape of each of the perforations 27 may vary. Perforations 27 shown in
The density and/or total number of perforations 27 may also vary. For example, perforations 27 may be more or less numerous on various surfaces of tray 1 and/or cover 3. The density of perforations 27 may also vary across individual surfaces, for example, increasing in density near the longitudinal middle of each of the side and/or end walls. In other embodiments, the density may increase near the intersection between each of the side and end walls, i.e., at the corners of tray 1. In the particular embodiment shown in
The cross-sectional size of each individual perforation may also vary. In some embodiments, the cross-sectional width or diameter of each perforation may range from about 0.1 to about 5.0 cm, about 0.1 to about 3.0 cm, about 0.3 to about 2.5 cm, about 0.5 to about 2.0 cm, or about 1.0 to about 1.5 cm.
In alternative embodiments, some or all of perforations 27 may be replaced with one or more large openings. Such openings may be sized such that tray 1 comprises a box-like frame with visibly exposed wire supports 31 therein. In addition or alternatively, perforations 27 may be shaped to correspond to the size and/or shape of the particular instruments and/or implants held within cavity 29. For instance, an elongated, elliptical perforation may be positioned adjacent to a similarly elongated, elliptical instrument feature.
Tray 1 may be used in a variety of sterilization processes. Such processes may include high pressure sterilization, high heat sterilization, gas sterilization, and/or heated or cold chemical sterilization. Accordingly, tray 1 may withstand a variety of conditions and/or devices, e.g., autoclaves. Temperatures during sterilization may reach up to or exceed about 400° F. and pressures may reach up to or exceed about 50 psi above atmospheric pressure. Sterilants employed pursuant to various sterilization processes may include but are not limited to: steam, water, gas, ethylene oxide gas, glutaraldehyde, formaldehyde, alcohol, and/or hydrogen peroxide. Commercial sterilant formulas may include products such as Cidex®, Clidox®, and/or Alcide®.
A wide variety of medical instruments and/or implants may be stored, reprocessed, transported, or sterilized within tray 1. Among the many examples compatible with tray 1 include, but are not limited to: various cutting devices, drilling devices, clamping devices, and/or depressors. Instruments may be grouped according to specific medical protocols such that one tray 1 is configured to hold a particular set of instruments and/or implants required for a given surgery, for example. Medical instruments may be further arranged according to the order and/or frequency with which they are needed during a specific medical procedure.
Connection MeansTray 1 may further include connection means for anchoring wire supports 31 to tray 1. Connection means may comprise various structural components, end connectors, connector pieces, or receptacles removably attached to, permanently affixed to, or integrally formed within tray 1. In the exemplary embodiments depicted in
As shown particularly in
Each mounting fixture 39, 41 may comprise a plurality of receiving slots or holes 43, each slot or hole 43 with a defined depth configured to receive one insert 33 or 35 of a wire support 31. A typical depth for each slot or hole 43 may range from about 0.1 to about 2 inches. A cylindrical, vertical through-hole is used in one embodiment; such a through-hole receives a suitably formed insert 33, 35 of a wire support 31 and does not provide a “cup” in which sterilant fluid or debris may accumulate. By slidably inserting each insert 33, 35 into a different receiving slot or hole 43, the inserts of each wire support 31 may be moved to various positions along the length of tray 1. Thus, each wire support 31 may be re-positioned as desired by a user to accommodate different instruments and/or implants. Wire supports 31 may be repositioned for storage and handling. For instance, numerous wire supports 31 may be stored in tray 1 during periods of non-use to avoid losing wire supports 31 and protect them from damage.
While in one embodiment a wire support 31 may be supported by inserts 33, 35 that are inserted at slots or holes 43 directly opposite each other, the configuration of a wire support 31 may lead to inserts 33, 35 that do not land in slots or holes 43 directly opposite each other; rather one insert 33 or 35 in a mounting fixture 39 or 41 may be displaced along the length of an opposing mounting fixture 39 or 41. Also, the configuration of a wire support 31 may, for example, lead to one insert 33, 35 inserted in a receiving slot or hole 43 of a mounting fixture 39, 41 on a side wall 11, 13, or one receiving slot or hole 43 on a side wall 11, 13 and one slot or hole 43 in a mounting fixture 39, 41 on an end wall 7, 9. Additionally, both inserts 33 and 35 may be inserted into different receiving slots or holes 43 on the same mounting fixture 39 or 41. The linear array of receiving slots or holes 43 of a mounting fixture 39 or 41, as shown in
The number of receiving slots or holes 43 included in each mounting fixture 39 and/or 41 may vary. As shown in
Receiving slots or holes 43 may be compatible with variously shaped wire supports 31. As such, the shape and diameter defined by each of the receiving slots or holes 43 may correspond precisely to the similarly shaped inserts 33, 35 of wire supports 31. For instance, as shown in
In other embodiments, the cross-sectional shape and/or size of wire supports 31 may vary, necessitating receiving slots or holes 43 of various shapes and/or sizes. For example, larger trays may include thicker wire supports 31, requiring receiving slots or holes 43 of greater width. Likewise, smaller trays 1 may comprise narrower receiving slots or holes 43 to more tightly receive correspondingly narrow inserts 33, 35. In other embodiments, receiving slots or holes 43 may comprise various additional shapes, e.g., square, rectangular, hexagonal, triangular, and/or irregular, to accommodate the cross-sectional designs of various wire supports 31 and/or maintain sterilant access to the interior of receiving slots or holes 43 and the inserts 33, 35 secured therein.
In additional embodiments, the diameter of each of the receiving slots or holes 43 may be adjusted by various means. For example, in one embodiment, receiving slots or holes 43 may each comprise an expandable portion or joint. Such expansion points may be manually adjusted by a user via a rotatable knob, for example. Other embodiments may comprise additional or alternative adjustment means. By enabling size adjustment of receiving slots or holes 43, individual mounting fixtures may be compatible with wire supports 31 of varying cross-sectional thickness and/or shape.
In addition or alternatively, inserts 33 and/or 35 of each wire support 31 may comprise spring-loaded mechanisms, e.g., latches or pins, for locking such inserts in place upon insertion into each receiving slot or hole 43 of mounting fixture 39, 41, or other end connector structures. According to such embodiments, a laterally-outward extending, spring-loaded latch or pin on each insert 33, 35 may compress upon insertion into a receiving slot or hole 43, remaining in a compressed state until each insert is fully inserted into the receiving slot or hole 43, at which point the spring-loaded latch or pin emerges through the bottom of the receiving slot or hole 43, springing laterally outward to prevent the insert from sliding upward through the receiving slot or hole 43 and thereby securing each wire support 31 in place. Such embodiments may be particularly necessary for receiving slots or holes of lesser depth, or horizontally-oriented receiving slots or holes unable to rely on gravity for securing inserts therein. Receiving slots or holes may comprise additional features for receiving such spring-loaded mechanisms, including lateral voids or cut-outs within each slot or hole 43 that correspond in size and shape to the latch or pin located on each insert. Upon proper alignment and full insertion of each insert into a receiving slot or hole 43, the void or cut-out receives the laterally-extending latch or pin and secures it in place until released by a user, for example.
Connection means, such as mounting fixtures 39, 41, may be permanently fixed to tray 1. In one embodiment, the connection means may comprise lock washers over-molded into side walls 11, 13. Alternatively, the connection means may be removably attached to tray 1. This may facilitate cleaning of a long contact surface between the structural pieces of the connection means and the associated vertically-oriented walls to which they are attached, which may be insufficiently exposed during sterilization. According to such embodiments, the connection means may be attached by various means. For example, mounting fixtures 39, 41 may be snapped onto the side and/or end walls of tray 1. In embodiments, various screws, adhesives, or locking mechanisms may be used to attach various connection means, including mounting fixtures 39, 41 and/or other end connectors, to tray 1.
In additional embodiments, the connection means may comprise variously-structured end connectors integrally formed within tray 1. As shown in the cross-sectional view of tray 1 in
Tray 1 also comprises one or more wire supports 31. Each wire support 31 may include at least two inserts 33 and 35 (one at each end) that flank an elongated middle portion 37, the middle portion comprising at least two bends and at least one contact segment, i.e., a length of wire that contacts an instrument to hold or support some portion of it.. The inserts 33 and 35 are in one embodiment used to anchor the wire supports 31 to one or more of the side walls 11, 13 of tray 1. A wire support 31 may form a continuous path between the side walls 11, 13 of tray 1. As shown in
In the side view of tray 1 shown in
As shown in
In additional designs, wire supports 31 may also pass over a top surface of various instruments and/or implants to prevent vertical movement of such objects toward cover 3, for instance. Wire supports 31 configured accordingly may be secured to tray 1 via connection means after the instruments and/or implants are initially placed on a first set of wire supports 31 that extend primarily around the bottom surfaces of the instruments. Such wire supports 31 may be utilized to further stabilize a set of instruments and/or implants upon inversion of tray 1, for example.
Wire supports 31 may be formed from wire or other thin, elongated stock of various cross-sectional shapes, sizes, and/or materials. In some embodiments, for example, wire supports 31 may comprise solid, circular cross sections. The cross-sectional shape may also be rectangular, oval, triangular, pentagonal, hexagonal, or irregular. In one embodiment, a circular or oval cross-section is used to cause wire supports 31 to contact instruments and/or implants only at points or lines of tangential contact therebetween. Such cross-sectional shapes may be solid or hollow. When bent, wire supports 31 may form smooth, rounded corners, such as those depicted in
The materials comprising wire supports 31 may vary. In some embodiments, for example, wire supports 31 may comprise copper, one or more metals, steel, stainless steel, or any combination thereof. In a particular embodiment, 300 series stainless steel may be used. In additional or alternative embodiments, wire supports 31 may be galvanized steel or coated with various materials, e.g., sealants, to further protect wire supports 31 from damage and/or to minimize frictional forces between wire supports 31 and the instruments and/or implants placed thereon.
The cross-sectional diameter of each wire support 31 may also vary. In some embodiments, the diameter or width (if the cross-section is not generally round), may be increased to support heavier objects, or decreased for lighter objects. The diameter of the wire may also be decreased to accommodate a greater number of objects within tray 1 and/or to minimize the size of the surface contact areas between the instruments and wire supports 31. In some embodiments, the cross-sectional thickness of wire supports 31 may range from about 0.05 to about 0.3 inches, about 0.075 to about 0.25 inches, about 0.1 to about 0.2 inches, about 0.125 to about 0.175 inches, or about 0.14 to about 0.16 inches.
Due in part to their narrow cross-sectional diameter, wire supports 31 do little or nothing to disturb, impede, or otherwise direct the flow of air, steam, and/or various other sterilants circulating throughout tray 1 during sterilization processes, in particular as compared to more planar support elements of conventional trays. As a result, instruments and/or implants sterilized within tray 1 may be thoroughly sterilized on a consistent basis. The narrow diameter of wire supports 31 also minimizes the internal bulk of tray 1, which may decrease the overall weight of the tray and enable tray 1 to accommodate a greater number of objects at one time. Such small, compact, and dense wire supports 31 may also be less vulnerable to cracking during intense heat, pressure, and chemical treatments. With a smaller surface area compared to other support structures in the prior art, the likelihood of wire supports 31 becoming contaminated after sterilization may also be reduced.
As illustrated in
As shown in
In the particular embodiments illustrated in
In contrast to wire support a, wire support b is entirely parallel to end wall 7, featuring inserts 33 and 35 secured to receiving slots or holes 43 equidistant from end wall 7. The contours defined by wire support b primarily restrict lateral movement of the instruments held therein with respect to side walls 11 and 13.
The vertical segments defined by the series of bends restrict the first instrument from moving toward side walls 11 and 13, and further restrict the knob portion from moving toward end wall 7 (not shown). After supporting the knob portion of a second instrument in similar fashion, wire support d extends back toward side wall 11, comprising a series of bends collectively defining vertically-undulating contours that prevent the knob portions of the first two instruments from moving toward end wall 9. Wire support d then extends horizontally toward side wall 13 for a distance, bending vertically upward and then horizontally away from side wall 9 to accommodate the handle portion of a third instrument. A series of additional bends define wire segments extending vertically and horizontally to abut the handle portion from different sides, thereby restricting movement of the handle portion toward each side and end wall. The final segment of wire support d extends horizontally toward side wall 13, where end insert 35 couples with mounting fixture 41. The customized collection of bends, loops, and contours comprising wire support d may embody a representative example of the specialized fit provided by the wire supports 31 disclosed herein. As shown, various segments of each wire support 31 may be oriented in various directions to accommodate different instrument and/or implant features. Such segments may comprise contours, bends, slots, or loops of various shapes, widths, and/or depths to suspend the instruments and/or implants a distance above floor member 5 within cavity 29. Despite the custom fit of the wire supports 31 with respect to the sterilization targets held thereon, and the resulting restriction in movement of such instruments, the contact surfaces between the wire supports 31 and the instruments and/or implants may be minimized.
As shown in each of
Floor member 5, cover 3, side walls 11 and 13, and end walls 7 and 9 of tray 1 may be manufactured from a single sheet of metal, for example, by stamping and bending methods. In other embodiments, the various components of tray 1 may be manufactured from multiple pieces or sheets of metal. Such components may be coupled together via rivets, screws, pins, or other mechanical fasteners via heat, sonic, laser, or spot welding. Alternatively, tray 1 can be manufactured in substantially unitary form by bending or other forming operations on a sheet of material with the desired perforations. Suitable materials for tray 1 and cover 3 include, but are not limited to, one or more metals, steel, stainless steel, plastics and other durable polymers, composite materials, and combinations thereof. Preferably, the materials have or can be provided with the desired perforations and are able to withstand the elevated heat and pressure conditions, as well as chemical treatments, commonly associated with sterilization processes.
Connection means comprising mounting fixtures 39 and 41 may be comprised of various materials. Suitable materials include, but are not limited to, one or more metals, steel, stainless steel, plastics and other durable polymers, composite materials, and combinations thereof. In one particular embodiment, mounting fixtures 39, 41 may be formed from Radel® polyphenylsulfone. In additional or alternative embodiments, various sulfone polymers may be utilized. The material may be the same or different as the material comprising the other structural components of tray 1. In one embodiment, mounting fixtures 39, 41 may be formed by injection molding one or more polymer compositions. Various adhesives, hooks, and/or fasteners, e.g., screws or bolts, may be utilized to secure the connection means to tray 1, as necessary.
Wire supports 31 may be manufactured by various methods of bending wire to assume particular conformations, which may require the application of heat and/or use of wire-bending machinery. Such machinery may receive stocks of wire fed directly into the machinery. Such machinery may then introduce one or more bends into the wire in two or more dimensions and at specific locations along the wire length. The machinery may further cut the wire at predefined lengths.
As seen in
As can be seen, a contact segment or a connection segment can be fully defined by its length and its end points (represented as dots in
The data needed to design a support 31 (which will usually be one of a set of supports) with contact segments, connection segments, and bends is a dimensional design description of the sterilization target(s) to be held and supported and a dimensional design description of the tray, which in turn defines the sterilization space or cavity 1250 of the tray in which an instrument or other sterilization targets is to be held and supported by one or more supports 31. With these data, a designer can select for a given instrument its location in the sterilization space or cavity 1250 of the tray. Once the location is known, the various contact segments and contact points for holding and support of the instrument can be selected and defined. For example, the horizontal contact segment 1220 may be selected to hold and support the instrument above the floor of the tray, while the two vertical contact segments 1222, 1224 may be selected to provide holding and support against lateral movement.
While a skilled designer in possession of the above dimensional design description data can design a wire support starting from a first insert (e.g., insert 33 in
After defining the specific location and arrangement for sterilization targets within the sterilization space corresponding to an actual tray, which leads to an x, y, z dimensional map of each target in the virtual cavity, a user may define the specific desired contact points for holding and supporting the sterilization targets, by location in the virtual cavity of desired contact points between a target and a wire contact segment that contacts a selected point of the target. (In some cases, depending on the shape of the surface of a sterilization target, the “contact point” may be a contact line or a contact surface; however, to facilitate contact of sterilization fluid with instrument surfaces, a limited contact line or a contact surface is preferred. In the following description, “contact point” may also mean a contact line or a contact surface.). This then allows a support wire designer to choose the contact segments needed in a particular wire support 31 and the bends needed to connect segments, starting with a wire support insert at a particular location on a connection means, to position a contact segment that will contact the selected point of the target.
The path of the wire support to and from a wire segment that will contact the selected contact point of the target, may be constrained by the minimum bending radius available for a particular wire diameter and material used and the specific bending capabilities of the wire bending machine that is to be programmed. However, with available bends between 80 and 179 degrees essentially all desired configurations can be built (keeping in mind that adjacent wire supports can contribute to the holding and support of a common instrument for which both wires provide contact segments. The design process may entail identifying multiple contact points based on the specific structural configuration of each target. The multiple contact points on an elongated target may be assigned to separate wire supports. Bends and the points where they begin and end may be specified, by the direction radius and radius center-point of each bend, such that the various contours defined by such bends lead into the contact segments providing the selected contact points of a given wire support with each target the support is designed to contact. The number of wire supports necessary to hold and support each target at its selected location may also be specified. The design of a target of known dimensions and located at particular x, y, z position selected in the sterilization space defined for a specific tray may be translated into a design of one or more wire supports configured to hold and support the target, with a beginning insert at one connection means and an ending insert at another connection means.
For most applications, the wire supports needed can each be defined in terms of: (1) the known configuration for each end (e.g., a short vertical segment for receipt in a receiving slot or hole 43 of mounting fixture 39, 41, or other end connector structure); (2) the shape or path of the wire support as it extends between the sides of a tray, defined in terms of 90 degree angle bends (or other angles) and the orientation of such bends (radius and radius center-point); and (3) the length of the contact and connection segments between bends. This can result in a relatively straightforward design file for the control of a wire bending machine that will produce a complex shape. The design file may be provided in a format that is an acceptable input format for a specific wire bending machine.
For wire supports configured in one plane, a two-dimensional wire bending machine able to handle the desired wire stock is sufficient, such as a Model 4S-6 from Mang Systems, Inc. of Mathews, N.C. or a Model AFE-2Dx from Automated Industrial Machinery, Inc. of Addison, Ill. For a wire support that is not in one plane, a three-dimensional wire bending machine able to handle the desired wire stock is needed, such as a Model 6S-6 from Mang Systems, Inc. of Mathews, N.C. or a Model AFM 3DX from Automated Industrial Machinery, Inc. of Addison, Ill. For more complex shapes, a wire bending machine that can bend angles other than 90 degree angle bends and/or form arcs, curves or other more complex shapes may be needed. Such a machine may have additional axes, e.g., up to 16 axes, for bending the wire into more complex shapes.
An example as shown in
The portion of the wire path that includes connection segment 1460 has an orientation that is in the longitudinal direction of the tray, and leads via a bend to a connection segment 1462 that has an orientation that is in the transverse direction of the tray. Connection segment 1462 leads via a bend to an angled descending contact segment 1464 and an arcuate bend positioned at a defined height above the tray floor. The arcuate bend leads into an angled ascending contact segment 1466 and an arcuate bend leading to contact segment 1468. These segments are part of this wire path, but are intended to provide holding of the enlarged end of instrument 1316 of
Ann appropriately formatted file with a description of a specific set of instruments and/or implants or components thereof may be stored and used to prepare an appropriately formatted file with a description of a specific set of wire supports for these instruments and/or implants or components. This file may be input into a process control component of the wire-forming machinery. Such machinery may then bend a stock wire to provide one or more wire supports 31 configured for attachment within tray 1 and custom fit to the particular set of instruments and/or implant components input by a user.
As used herein, the term “targets” refers primarily to assorted medical instruments and/or implants or components thereof; however, “objects” may also include various devices, equipment, and/or waste materials that may necessitate one-time or periodic sterilization.
While the tray and method have been described with reference to exemplary embodiments, it will be understood by those skilled in the art that various changes can be made and equivalents may be substituted, without departing from the spirit and scope of the disclosure. In addition, modifications may be made to adapt the teachings of the invention to particular situations and to use other materials, without departing from the essential scope thereof. The tray and method are thus not limited to the particular examples that are disclosed here, but encompass all of the embodiments falling within the scope of the claims.
Claims
1. A tray for holding sterilization targets comprising:
- a perforated floor member;
- a plurality of vertically oriented walls connected to the floor member around a perimeter of the floor member such as to define an internal cavity, wherein one or more of the walls may be perforated;
- at least one wire support for removably holding and supporting against lateral or longitudinal movement at least one sterilization target within the internal cavity, wherein each wire support comprises two ends and a middle portion, the middle portion comprising at least two bends in a wire from which the support is made; and
- connection means associated with at least one of the plurality of vertically oriented walls for securing each end of the at least one wire support to the tray.
2. The tray of claim 1, further comprising a cover piece removably attached to the vertically oriented walls and positioned opposite the floor member.
3. The tray of claim 2, wherein the cover piece is configured to snap onto the plurality of vertically oriented walls.
4. The tray of claim 1, further comprising at least one caddy configured to attach to the tray via the connection means.
5. The tray of claim 4, wherein the caddy comprises one or more slots, holes, baskets, and/or cavities configured to removably hold one or more small sterilization targets therein.
6. The tray of claim 4, wherein the caddy comprises one or more perforations.
7. The tray of claim 1, wherein the at least one wire support is configured to suspend at least one sterilization target a distance above the floor member such that sterilants employed during sterilization processes contact each surface of the sterilization target and a sterilant flow within the tray is improved relative to trays lacking a distance between the floor member and at least one sterilization target suspended thereabove.
8. The tray of claim 1, wherein the at least one wire support comprises various contoured, bent, or curved portions customized to removably hold or support a specific set of sterilization targets such that the sterilization targets remain stationary within the internal cavity.
9. The tray of claim 1, wherein the at least one wire support does not contact the perforated floor member.
10. The tray of claim 1, wherein the tray is configured to simultaneously hold about 1 to about 10 sterilization targets.
11. The tray of claim 1, wherein the tray comprises at least two or more wire supports configured to support a sterilization target at two or more contact points along its length.
12. The tray of claim 1, wherein the tray comprises at least one wire support supported on at least two of the plurality of vertically oriented walls.
13. The tray of claim 1, wherein the at least one wire support is comprised of one or more materials selected from the group consisting of one or more metals, steel, stainless steel, galvanized steel, copper, aluminum, one or more polymers, and any other materials suitable for sterilization.
14. The tray of claim 1, wherein the at least one wire support has a cross-sectional thickness of about 0.05 to about 0.3 inches.
15. The tray of claim 1, wherein the tray comprises four vertically oriented walls, including two oppositely-facing side walls and two oppositely-facing end walls.
16. The tray of claim 16, wherein the tray comprises a plurality of perforations on each of the two side walls, the floor member, and a cover piece.
17. The tray of claim 1, wherein the connection means comprise at least one mounting fixture further comprising a plurality of receiving slots or holes, the mounting fixture arranged along one or more walls, wherein the at least one wire support is removably secured to the mounting fixture by inserting an end of the wire support into one of the plurality of receiving slots or holes.
18. The tray of claim 17, wherein the tray comprises two mounting fixtures, each mounting fixture secured along a vertically-oriented wall.
19. The tray of claim 17, wherein each of the receiving slots is compatible with ends of variously configured wire supports, such that the wire support ends may be inserted into different receiving slots or holes as desired by a user.
20. The tray of claim 17, wherein the receiving slots or holes each comprise a depth of about 0.1 to about 2 inches.
21. The tray of claim 17, wherein the receiving slots or holes are cylindrical.
22. The tray of claim 1, wherein the tray is configured to the internal cavity for steam and/or chemical sterilization processes.
23. A tray for holding sterilization targets comprising:
- a perforated floor member;
- a plurality of vertically oriented walls connected to the floor member around a perimeter of the floor member such as to define an internal cavity, wherein one or more of the walls may be perforated;
- at least one wire support for removably holding and supporting against lateral or longitudinal movement at least one sterilization target within the internal cavity, wherein each wire support comprises two ends and a middle portion, the middle portion comprising at least two bends; and
- at least one end connector configured to secure an end of at least one wire support to the tray.
24. The tray of claim 23, wherein the at least one end connector is comprised of one or more structures selected from the group consisting of a perforated, bent top edge of a vertically oriented wall, a receiving space for a latch or pin, and other connecter structure suitable for securing the at least one wire support to the tray.
25. A method of forming a wire support for use in a tray for holding sterilization targets comprising: (i) a perforated floor member; and (ii) a plurality of vertically oriented walls connected to the floor member around a perimeter of the floor member, wherein one or more of the walls may be perforated and the floor member and walls together define a sterilization space enclosed by the tray, comprising:
- using a computer aided design tool programmed with a dimensioned design description for the tray for holding sterilization targets, including the sterilization space, defining a location in the sterilization space for at least one sterilization target;
- using a computer aided design tool programmed with a dimensioned design description for the at least one sterilization target, identifying at least one contact point on the sterilization target, for supporting or positioning the sterilization target at its location in the sterilization space;
- using a computer aided design tool programmed with the bending capabilities of a wire bending machine and a wire specification, defining a wire path between two connection means associated with at least one of the plurality of vertically oriented walls for securing each end of the at least one wire support to the tray, said wire path defining a wire configuration extending between two end points of at least one wire support segment and passing through the at least one contact point and at least one wire connection segment at each end of the wire support segment defined by a connecting bend in the wire path;
- storing in a storage medium a wire path design file including the location of a plurality of end points of the support segments and connection segments and a radius or other specification of the connecting bends, said wire path forming a continuous path between the two connection means;
- transmitting to the control unit of the wire bending machine the wire path design file; and
- causing the wire bending machine to perform bending of a wire supplied to the bending machine as defined by the wire path design file, including forming an insert for each of the connection means by bending and cutting wire at each end of the wire path.
26. The method of claim 25, wherein defining a location in the sterilization space for at least one sterilization target comprises arranging two or more sterilization targets within the sterilization space according to an order of use in a corresponding medical operation or task, such that the targets may be progressively removed from the tray in the order with which they are arranged.
27. The method of claim 25, wherein defining a location in the sterilization space for at least one sterilization target comprises suspending the at least one sterilization target a distance above the perforated floor member within the sterilization space.
28. The method of claim 25, wherein the at least one contact point comprises a contact line or a contact surface.
29. The method of claim 25, wherein defining a wire path further comprises specifying a wire thickness.
30. The method of claim 25, wherein the computer aided design tool comprises two-dimensional or three-dimensional modeling capabilities.
31. The method of claim 25, wherein the radius or other specification of the connecting bends comprises points where the connecting bends begin and end, a direction radius and a radius center-point of each bend, such that various contours defined by the connecting bends lead into contact segments and connection segments.
32. The method of claim 25, further comprising selecting a number of wire supports necessary to hold and support the at least one sterilization target at its defined location.
33. The method of claim 25, wherein defining a wire path between two connection means further comprises selecting a location on each of the connection means for securing each end of the at least one wire support to the tray.34. The method of claim 25, wherein the wire path comprises various straight, angled, contoured, bent, or curved portions.
35. The method of claim 25, wherein the wire is comprised of one or more materials selected from the group consisting of one or more metals, steel, stainless steel, galvanized steel, copper, aluminum, one or more polymers, and any other materials suitable for sterilization.
36. The method of claim 25, wherein the at least one wire support has a cross-sectional thickness of about 0.05 to about 0.3 inches.
Type: Application
Filed: Jul 27, 2016
Publication Date: Feb 1, 2018
Inventors: Alexander McLaughlin (Isanti, MN), Doug McLane (Elk River, MN)
Application Number: 15/220,757